FDA-Device2016-12-14Class I
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
SynCardia Systems Inc.
Hazard
The Main Printed Circuit Board Assembly (PCBA) of the affected Freedom Drivers may fail and cause the Freedom Driver to stop functioning without visual or audible alarms, resulting in the loss of life-sustaining function.
Sold states
US distribution to Virginia and Arizona.
Affected count
5
Manufactured in
1992 E Silverlake Rd, N/A, Tucson, AZ, United States
Products
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0659-2017Don't want to check this manually?
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